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Millions of people, particularly in low- and middle-income countries, lack access to effective pharmaceuticals, often because they are unaffordable. The 2001 Ministerial Conference of the World Trade Organization (WTO) adopted the Doha Declaration on the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement and Public Health. The declaration recognized the implications of intellectual property rights for both new medicine development and the price of medicines. The declaration outlined measures, known as TRIPS flexibilities, that WTO Members can take to ensure access to medicines for all. These measures include compulsory licensing of medicines patents and the least-developed countries pharmaceutical transition measure. The aim of this study was to document the use of TRIPS flexibilities to access lower-priced generic medicines between 2001 and 2016. Overall, 176 instances of the possible use of TRIPS flexibilities by 89 countries were identified: 100 (56.8%) involved compulsory licences or public noncommercial use licences and 40 (22.7%) involved the least-developed countries pharmaceutical transition measure. The remainder were: 1 case of parallel importation; 3 research exceptions; and 32 non-patent-related measures. Of the 176 instances, 152 (86.4%) were implemented. They covered products for treating 14 different diseases. However, 137 (77.8%) concerned medicines for human immunodeficiency virus infection and acquired immune deficiency syndrome or related diseases. The use of TRIPS flexibilities was found to be more frequent than is commonly assumed. Given the problems faced by countries today in procuring high-priced, patented medicines, the practical, legal pathway provided by TRIPS flexibilities for accessing lower-cost generic equivalents is increasingly important. Des millions de personnes, en particulier dans les pays a revenu faible et intermediaire, ne peuvent acceder a des produits pharmaceutiques efficaces, souvent en raison de leur prix trop eleve. La Conference ministerielle de 2001 de l'Organisation mondiale du commerce (OMC) a adopte la Declaration de Doha sur l'Accord sur les ADPIC (aspects des droits de propriete intellectuelle qui touchent au commerce) et la sante publique. Cette declaration a reconnu les implications des droits de propriete intellectuelle, aussi bien pour le developpement de nouveaux medicaments que pour le prix des medicaments. Elle a detaille des mesures, appelees flexibilites des ADPIC, que peuvent prendre les Membres de l'OMC pour assurer l'acces de tous aux medicaments, comme l'octroi de licences obligatoires aux brevets de medicaments et la mesure de transition pharmaceutique des pays les moins avances. Le but de cette etude etait d'examiner le recours aux flexibilites des ADPIC pour acceder a des medicaments generiques moins couteux entre 2001 et 2016. Dans l'ensemble, 176 cas de recours possible aux flexibilites des ADPIC par 89 pays ont ete releves: 100 (56,8%) concernaient des licences obligatoires ou des licences d'utilisation publique a des fins non commerciales et 40 (22,7%) concernaient la mesure de transition pharmaceutique des pays les moins avances. Quant aux autres, il s'agissait d'un cas d'importation parallele, de 3 exceptions de recherche et de 32 mesures sans lien avec des brevets. Sur ces 176 cas, 152 (86,4%) ont ete mis en oeuvre. Ils portaient sur des produits destines a traiter 14 maladies differentes. Cependant, 137 (77,8%) concernaient des medicaments contre le virus de l'immunodeficience humaine et le syndrome d'immunodeficience acquise ou des maladies apparentees. Le recours aux flexibilites des ADPIC s'est revele plus frequent que ce que l'on supposait. Etant donne les problemes que rencontrent actuellement certains pays pourse procurer des medicaments brevetes a prix eleve, le cadre pratique et juridique offert par les flexibilites des ADPIC pour acceder a des equivalents generiques moins couteux revet une importance de plus en plus capitale. Millones de personas, particularmente en paises de ingresos bajos y medios, carecen de acceso a medicamentos efectivos, habitualmente porque no pueden pagarlos. La Conferencia Ministerial de 2001 de la Organizacion Mundial del Comercio (OMC) adopto la Declaracion de Doha relativa al Acuerdo sobre los ADPIC (Aspectos de los Derechos de Propiedad Intelectual relacionados con el Comercio) y la Salud Publica. La declaracion reconocio las implicaciones de los derechos de propiedad intelectual para el desarrollo de nuevos medicamentos y el precio de los mismos. La declaracion describio medidas, conocidas como flexibilidades de los ADPIC, que los Miembros de la OMC pueden tomar con el objetivo de asegurar el acceso a los medicamentos para todos. Estas medidas incluyen concesion obligatoria de licencias de patentes de medicamentos y la medida de transicion farmaceutica de paises menos desarrollados. El objetivo de este estudio fue documentar el uso de las flexibilidades de los ADPIC para acceder a medicamentos genericos de precio inferior entre el 2001 y el 2016. En general, se identificaron 176 casos de posibles usos de las flexibilidades de los ADPIC: 100 (56.8%) implicaron licencias obligatorias o licencias de uso publico no comercial y 40 (22.7%) apelaron a la medida de transicion farmaceutica de paises menos desarrollados. El resto fue: 1 caso de importacion paralela; 3 excepciones de investigacion; y 32 medidas no relacionadas con patentes. De los 176 casos, 152 (86.4%) se implementaron. Cubrieron productos para tratar 14 enfermedades diferentes. Sin embargo, 137 (77.8%) implicaron medicamentos para la infeccion del virus de inmunodeficiencia humana y el sindrome de inmunodeficiencia adquirida o enfermedades relacionadas. Resulto que el uso de las flexibilidades de los ADPIC fue mas frecuente de lo que comunmente se espera. Dados los problemas que enfrentan hoy los paises en la adquisicion de medicamentos de alto precio y patentados, el camino practico y legal que ofrecen las flexibilidades de los ADPIC para acceder a equivalentes genericos de costo inferior es cada vez mas importante. [phrase omitted], Introduction The challenges posed by the high price of antiretroviral medicines in the late 1990s, coupled with widespread patenting of these medicines, led to efforts to ensure that the World [...]

Most countries have acceded to at least one global or regional covenant or treaty confirming the right to health. After years of international discussions on human rights, many governments are now moving towards practical implementation of their commitments. A practical example may be of help to those governments who aim to translate their international treaty obligations into practice. WHO's Essential Medicines Programme is an example of how this transition from legal principles to practical implementation may be achieved. This programme has been consistent with human rights principles since its inception in the early 1980s, through its focus on equitable access to essential medicines. This paper provides a brief overview of what the international human rights instruments mention about access to essential medicines, and proposes five assessment questions and practical recommendations for governments. These recommendations cover the selection of essential medicines, participation in programme development, mechanisms for transparency and accountability, equitable access by vulnerable groups, and redress mechanisms.

The government of Democratic Yemen started an essential drugs programme in 1984. Every month quantities of 30 drugs are delivered in prepacked kits to health units and standard treatment schedules have been agreed. The quantities of each drug were estimated by applying the standard treatment schedules to the typical morbidity patterns seen at these facilities. Most health workers attended a training course on the correct use of the standard treatment schedules. Hospital and health centres have been included in the programme to a more limited extent. In March 1988 an evaluation of the programme was carried out. Comparisons were made between random samples of health units included in the programme and those where it had not yet been implemented. The adequacy of knowledge necessary for reasonable use of drugs was assessed by interviewing health workers. Actual drug prescription was studied by means of quantitative indicators. A more qualitative insight was obtained by reviewing drug prescriptions for four tracer diseases at a sample of health centre and hospital out-patient departments. Health workers at units included in the programme had significantly (P < 0.05) higher levels of rational drug knowledge and 'better' actual drug prescription in terms of proportions of patients receiving injections (25% vs 58%), antibiotics (45% vs 67%) and the average number of drugs per patient (1.5 vs 2.4)--all P < 0.001. Many patients treated at health centres and hospitals were receiving irrational drug treatment for the tracer conditions. It is suggested that the methods used in this evaluation to measure rational drug prescription could be appropriate in the assessment of other essential drugs programmes.

In 2008 the UN Special Rapporteur on the Right to Health published 72 right to health indicators in 194 health systems. We present a follow-up report of eight indicators for access to medicines to serve as a reference point for progress towards SDG Target 3.8 on essential medicines. Data for these eight indicators in 2015 were collected and compared with the 2008 report. Between 2008 and 2015 we observed increased numbers of constitutions recognising access to medicines (7-13 countries), countries with a national medicine policy (118-122) and with a national list of essential medicines (78-107). Public spending on pharmaceuticals decreased or rose modestly in most of the 44 countries. Median availability of a basket of lowest-priced generics increased in the public (63%-70% n = 9 countries) and private (84%-92% n = 10) sectors. Median child immunisation rates remained constant for measles (around 90%) and improved for three doses of diphtheria-tetanus-pertussis (79%-86%). These eight indicators are useful and feasible, but should be further strengthened and expanded. Future monitoring exercises should use these indicators to screen progress and guide national governments' action to ensure universal access to essential medicines as part of the right to health. [ABSTRACT FROM AUTHOR]